Patients aged 14 years or older with an acute first-time or recurrent patellar dislocation Musculoskeletal Diseases
Conditions
Interventions
Participants will be randomly allocated 1:1 using a web-based service to “supervised rehabilitation” or “self-managed rehabilitation”. Randomisation will be stratified by study site and first-time/re
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
14 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged =14 years 2. First-time or recurrent patellar dislocation confirmed if: 2.1. The patellar dislocation was reduced by a healthcare professional or 2.2. The patient reports a visible lateral patellar dislocation or sensation of the patella ‘popping out’ of joint followed by reduction and the assessing clinician diagnoses a lateral patellar dislocation 3. Willing and able to provide informed consent (patients aged =16 years), or for patients aged <16 years the parent is willing and able to provide informed consent for their child’s participation and the patient is able to provide assent should they wish to do so
Exclusion criteria
Exclusion criteria: 1. >14 days from injury 2. Previous patellar stabilisation surgery on the affected knee 3. Requires acute surgical intervention (e.g., due to concurrent osteochondral fracture) 4. Contraindication(s) to participation in the study interventions 5. Patient is unable to adhere to study procedures 6. Previously randomised into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study aims to determine if a full-scale randomised controlled trial comparing supervised versus self-managed rehabilitation for people after acute patellar dislocation is feasible by assessing the: 1. Willingness to be randomised: proportion of eligible patients approached who are randomised over the recruitment period; 2. Recruitment rate: number of participants recruited per month per site over the recruitment period; 3. Intervention adherence: proportion of participants allocated to “supervised rehabilitation” and “self-managed rehabilitation” attending at least four physiotherapy sessions and one physiotherapy session, respectively; 4. Retention: proportion of participants that return KOOS4 outcome data at 9 months; and 5. Understanding participants’ experience of recovery, and the acceptability of the study interventions and follow-up methods to participants through semi-structured interviews conducted over the 9-month follow-up period | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess if the planned outcomes for the full-scale trial can be collected, we will collect them in this study. Secondary outcome measures are: 1. Knee symptoms and function measured by the average of four of five domains of the Knee Osteoarthritis Outcome Score (KOOS4) and all KOOS subdomains at baseline and 3, 6, and 9 months after randomisation 2. Health-related quality of life measured using the EuroQol 5 Dimensions (EQ-5D-5L) at baseline, and 3, 6 and 9 months after randomisation 3. Return to pre-injury sport/physical activity level using a using a trial specific questionnaire at baseline, and 3, 6 and 9 months after randomisation 4. Global rating of change measured using participant-reported rating of change in their injured knee compared to when they agreed to enter the study on a 7-point Likert Scale at 3, 6, and 9 months after randomisation 5. Adherence to prescribed exercise using a trial specific questionnaire at 3, 6 and 9 months after randomisation 6. Health resource use using a trial specific questionnaire at 3, 6 and 9 months after randomisation 7. Complications using a trial specific questionnaire and site reporting at 3, 6 and 9 months after randomisation | — |
Countries
England, United Kingdom
Contacts
Public ContactColin Forde
Outcome results
None listed